Drug-coated balloon alone versus atherectomy plus drug-coated balloon for treatment of femoropopliteal atherosclerotic disease: a meta-analysis

BACKGROUND: We performed a systematic review and meta-analysis to compare the safety and efficacy of drug-coated balloon (DCB) with atherectomy (AT) plus DCB alone for the treatment of femoropopliteal artery disease (FAD). METHODS: We searched PubMed, the Cochrane Library, and EMBASE up to 31 December 2024. Observational studies and randomized controlled trials comparing DCB alone versus AT combined with DCB in the treatment of FAD were included. Outcomes were categorized as procedural outcomes, including bailout stenting, flow-limiting dissection, distal embolization, perforation, and hematoma, and clinical outcomes, including primary patency at 12-month, freedom from target lesion revascularization (fTLR) at 12-month, leg amputation, and all-cause mortality. Two reviewers independently assessed study eligibility, extracted data, and evaluated the risk of bias. RESULTS: Eleven studies were included: 3 randomized controlled trials and 8 observational cohort studies, comprising 1296 participants. Compared to the AT + DCB group, when treating FAD, the DCB-alone group showed a higher incidence of bailout stenting (OR = 2.93, 95% CI [1.95, 4.39]; heterogeneity: I² = 7%) and flow-limiting dissection (OR = 4.46, 95% CI [2.53, 7.86]; heterogeneity: I² = 0%), but a lower risk of distal embolism (OR = 0.37, 95% CI [0.16, 0.84]; heterogeneity: I² = 0%). For other procedural outcomes, no significant differences were observed in perforation (OR = 0.66, 95% CI [0.28, 1.58]; heterogeneity: I² = 0%) or hematoma (OR = 0.83, 95% CI [0.38, 1.81]; heterogeneity: I² = 0%). For clinical outcomes, there were no significant differences between the two groups in fTLR at 12-month (OR = 0.81, 95% CI [0.57, 1.16]; heterogeneity: I² = 24%), primary patency at 12-month (OR = 0.92, 95% CI [0.68, 1.24]; heterogeneity: I² = 0%), all-cause mortality (OR = 1.15, 95% CI [0.74, 1.78]; heterogeneity: I² = 31%), or amputation (OR = 1.79, 95% CI [0.90, 3.56]; heterogeneity: I² = 0%). CONCLUSION: Our meta-analysis demonstrated that AT + DCB did not show significant clinical superiority over DCB alone in terms of 12-month primary patency or fTLR. This combined approach did, however, significantly reduce the occurrence of flow-limiting dissections and decrease the need for bailout stenting. This highlights its potential as a strategy for achieving "graft-free residual" treatment in FAD. If further technical refinements can reduce the higher risk of distal embolization seen with the addition of atherectomy, longer term clinical benefits may be realized by reducing the risk of ISR. Importantly, these findings emphasize the necessity for large-scale, multicenter randomized controlled trials with extended follow-up periods to confirm the clinical efficacy and safety of this combined therapeutic approach.